Comparing Integrative Interventions for Chronic Pelvic Pain (CII-CPP)

Sara Till, MD, MPH

Status: Completed

Conditions: Pelvic Pain

Treatments: Device: My Pelvic Plan; Behavioral: Bend

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07066345

K23HD099283 (U.S. NIH Grant/Contract)

HUM00273882

Details and patient eligibility

About

The researchers will conduct a pilot randomized trial to assess functional changes with two different remote integrative non-pharmacologic interventions for women with chronic pelvic pain (CPP). The study team will compare a novel web-based, cognitive-behavioral program designed for patients with CPP and a commercially available physical activity remote application. The team aims to gather information about differences in sexual function, physical function, pain, and quality of life.

Full description

My Pelvic Plan was determined as a medical device under FDA enforcement discretion.

Enrollment: 49 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Scheduled for a new patient visit with the Chronic Pelvic Pain and Endometriosis Referral Clinic within the Department of Obstetrics and Gynecology at the University of Michigan for treatment of chronic pelvic pain.
• Have chronic pelvic pain, defined as moderate to severe pelvic pain that is ≥ 4 on a 0-10 numeric rating scale (worst pain during the day) for ≥ 6-month duration, and is non-cyclic, occurring for at least 14 days of each month.
• Report moderate to severe sexual dysfunction or sexual restriction on CPP clinic intake questionnaire. This will be defined as the patient indicating one of the following responses to a question that asks them to describe their experience relative to sexual activity: my sex life is nearly normal but is very painful, my sex life is severely restricted by pain, my sex life is nearly absent because of pain, pain prevents any self life at all.
• Have access to internet via computer and must have a smartphone
• Willing to download and use the Bend application on their smartphone if they are randomized to that intervention
• English-language proficiency (current version of the My Pelvic Plan website is in English)

Exclusion criteria

• Pregnancy (at time of screening visit). Participants will be allowed to continue to study if they become pregnant during the study period.
• Severe physical impairment precluding participating in internet-based program or remote application (for example, complete blindness or deafness)
• Medical condition that precludes low-intensity, short-duration physical activity and gentle stretching, including cerebral palsy, severe hip or knee osteoarthritis, severe heart failure, severe Chronic obstructive pulmonary disease (COPD) requiring oxygen use
• Prior care within the Chronic Pelvic Pain and Endometriosis Referral Clinic within the Department of Obstetrics and Gynecology at the University of Michigan for treatment of chronic pelvic pain (seen previously but meets criteria for new patient visit because > 3 year interval since last clinic visit).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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49 participants in 2 patient groups

Group 1- My Pelvic Plan

Experimental group

Description:

Patients will be randomized to receive one of two non-pharmacologic interventions. Group 1 will receive access to a novel web-based, cognitive behavioral program.

Treatment:

Device: My Pelvic Plan

Group 2- Bend

Active Comparator group

Description:

Patients will be randomized to receive one of two non-pharmacologic interventions. Group 2 will receive a subscription to a commercially available remote application.

Treatment:

Behavioral: Bend